Status:
RECRUITING
Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population
Lead Sponsor:
University of Chicago
Conditions:
Enhanced Recovery After Surgery in a Pediatric Population
Eligibility:
All Genders
3-12 years
Phase:
PHASE1
PHASE2
Brief Summary
Dexmedetomidine (Dex), a selective α2-adrenergic receptor agonist, is the most used sedative for procedural sedation in children and in pediatric Intensive Care Unit (PICU) because it is associated wi...
Detailed Description
SCREENING DAY (-1-3) - PRIOR TO APPOINTMENT Only a single visit will take place prior to the MRI scan procedure. This will be done one to three days prior to the sedation procedure, via chart screenin...
Eligibility Criteria
Inclusion
- Undergo Magnetic Resonance Imaging (MRI) scan
- Age ≥3 and ≤ 12 yr old
- Both Male and Female
- Weight ≤33.3 kg
- American Society of Anesthesiologists ASA) physical status 1-3
- No History of Arrhythmia (3-leads Electrocardiogram \[EKG\] applied before and after the sedation) or congenital heart disease
- Capable of obtaining consent from at least one parent
- No history of liver and kidney impairment
- No history of head trauma
- No prior history of difficulty with anesthesia
- No personal or family history of malignant hyperthermia
Exclusion
- Age \<3 or \>12
- Weight \>33.3 kg
- ASA physical status \> 3
- History Arrhythmia, congenital heart disease, liver, and kidney diseases
- Prior difficulty with anesthesia
- Personal or family history of malignant hyperthermia
- Unable to obtain consent
- History of head trauma
- Female subjects who are pregnant
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06538584
Start Date
September 9 2024
End Date
December 31 2027
Last Update
September 12 2025
Active Locations (1)
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1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637